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Combined Therapies for Recurrent Brain Cancer

N/A

Recruiting

Research Sponsored by Monteris Medical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Target lesion must be amenable to undergo surgical biopsy and LITT treatment

Must not have

Patients with rapidly progressing extracranial disease

Patients with a serious active infection or other serious underlying medical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through 24 months or study exit (whichever comes first)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two sets of treatment algorithms for brain metastases patients who have had stereotactic radiosurgery.

Who is the study for?

This trial is for adults over 18 who've had brain metastases treated with SRS at least 3 months ago. They must be stable on low-dose steroids, able to undergo biopsy and laser therapy, and commit to the study's follow-up. Women of childbearing age need a negative pregnancy test and agree to use contraception.

What is being tested?

The REMASTer trial compares two treatment strategies after initial SRS for brain metastases: Radiation Therapy versus Laser Interstitial Thermal Therapy combined with Steroid Therapy. It's randomized, meaning patients are put into groups by chance.

What are the potential side effects?

Potential side effects include those related to radiation (fatigue, hair loss, skin irritation), laser therapy (swelling, pain at the site), and steroid therapy (weight gain, mood changes). Each patient may experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer can be biopsied and treated with laser therapy.

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I've been stable for 3 days on a low steroid dose.

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I am mostly able to take care of myself.

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My brain tumor is growing despite previous treatments.

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I am a woman and my pregnancy test was negative.

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I have brain metastases from a cancer that did not originate in the brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer outside the brain is quickly getting worse.

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I do not have any serious infections or other major health issues.

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I cannot have surgery due to my health condition.

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I have cancer that has spread to the lining of my brain and spinal cord.

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I cannot undergo or am not eligible for stereotactic radiosurgery.

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I am receiving treatment for another cancer besides the one being studied.

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I have more than 3 tumors that are getting worse.

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I have recently been diagnosed with brain metastases.

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I cannot take steroids due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment through 24 months or study exit (whichever comes first). measurements occur at baseline, post-op visit, 1 month visit, and each subsequent follow up visit until study exit or at 24 months, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progressive Disease Cohort

Radiation Necrosis Cohort

Secondary study objectives

Progressive Disease Cohort: Overall Survival

Radiation Necrosis Cohort: Freedom from Local Progression (FFLP) or Neurological Death

Other study objectives

Cognitive Measure- HVLT

Cognitive Measure- Trail Making Test

Describe Quality of Life (QoL) and cognition over time

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Recurrent TumorExperimental Treatment2 Interventions

Receives Laser Interstitial Thermal Therapy (LITT) followed by surveillance or Receives Laser Interstitial Thermal Therapy (LITT) followed by hypofractionated radiation therapy (RT).

Group II: Radiation NecrosisExperimental Treatment2 Interventions

Receives Laser Interstitial Thermal Therapy (LITT) and best medical management with steroids or Receives best medical management with steroids.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

Laser Interstitial Thermal Therapy

2014